Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT01966003 |
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Recruitment Status :
Completed
First Posted : October 21, 2013
Results First Posted : October 19, 2017
Last Update Posted : October 19, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-small Cell Lung Cancer Metastatic | Drug: Carboplatin Drug: Paclitaxel Drug: ABP 215 Drug: Bevacizumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 642 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Phase 3 Study Evaluating the Efficacy and Safety of ABP 215 Compared With Bevacizumab in Subjects With Advanced Non-Small Cell Lung Cancer |
| Actual Study Start Date : | November 11, 2013 |
| Actual Primary Completion Date : | July 23, 2015 |
| Actual Study Completion Date : | July 23, 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: ABP 215
Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
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Drug: Carboplatin
Administered at an area under the concentration-time curve (AUC) 6 by IV infusion Q3W
Other Name: Paraplatin Drug: Paclitaxel Administered 200 mg/m² IV Q3W
Other Name: Taxol Drug: ABP 215 Administered 15 mg/kg Q3W by IV infusion |
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Active Comparator: Bevacizumab
Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
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Drug: Carboplatin
Administered at an area under the concentration-time curve (AUC) 6 by IV infusion Q3W
Other Name: Paraplatin Drug: Paclitaxel Administered 200 mg/m² IV Q3W
Other Name: Taxol Drug: Bevacizumab Administered 15 mg/kg Q3W by IV infusion
Other Name: Avastin |
- Percentage of Participants With an Objective Response [ Time Frame: Disease assessments were performed at weeks 1, 7, 13, 19, and approximately every 9 weeks thereafter. The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively. ]
Tumor assessments were performed by central, independent, blinded radiologists according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest and abdomen. Objective response is defined as a best overall response of partial response (PR) or complete response (CR) as defined by RECIST v1.1. All participants who did not meet the criteria for CR or PR by the end of the study were considered non-responders.
CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must be reduced in short axis to < 10 mm.
PR: Disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions, or, at least a 30% decrease in the sum of diameters of target lesions, with no progression of existing non-target lesions and no new lesions.
- Duration of Response [ Time Frame: Disease assessments were performed at weeks 1, 7, 13, 19, and approximately every 9 weeks thereafter. The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively. ]
Duration of response (DOR) was calculated as the time from the first objective response (PR or CR) to disease progression per RECIST v1.1 based on the central, independent, blinded radiologists' review.
DOR was only calculated for participants with an objective response. For responders not meeting the criterion for progression by the end of the study, DOR was censored at the date of the last evaluable tumor assessment.
Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm, or, unequivocal progression of existing non-target lesions, or any new lesions.
- Progression-free Survival [ Time Frame: From randomization until the end of study; The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively. ]
Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression using RECIST v1.1 based on the central, independent, blinded radiologists' review, or death. Participants who were alive and did not meet the criteria for progression by the end of the study were censored at their last evaluable disease assessment date. Participants with no evaluable tumor assessments after randomization who did not die by the end of the study were censored on the randomization date.
Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm, or, unequivocal progression of existing non-target lesions, or any new lesions.
- Number of Participants With Adverse Events [ Time Frame: up to 19 weeks ]
Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4, and according to the following scale: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death due to AE.
A serious adverse event (SAE) is defined as an AE that meets at least 1 of the following serious criteria:
- fatal
- life-threatening
- required inpatient hospitalization or prolongation of existing hospitalization
- resulted in persistent or significant disability/incapacity
- congenital anomaly/birth defect
- other medically important serious event
- Number of Participants Who Developed Anti-drug Antibodies [ Time Frame: 44 weeks (6 months after end of treatment) ]Two validated assays were used to detect the presence of anti-ABP 215 antibodies. Samples were first tested in an electrochemiluminescence (ECL)- based bridging immunoassay to detect antibodies capable of binding to ABP 215 (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based target binding assay to determine neutralizing activity against ABP 215 (Neutralizing Antibody Assay). If a post-dose sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.
- Overall Survival [ Time Frame: From randomization until the end of study; The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively. ]
Overall survival (OS) was defined as the time from the randomization date to date of death. Participants alive at the end of study were censored at the last date known to be alive, derived from dates collected within the study that implied a participant was alive.
Participants were followed for survival status during the treatment phase and thereafter every 9 weeks until the end of the clinical study, consent was withdrawn, they were lost to follow-up, died, or had proscribed therapy (eg, commercial bevacizumab, non-study anti-cancer treatment).
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC)
- Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 cycles of chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
Exclusion Criteria:
- Small cell lung cancer (SCLC) or mixed SCLC and NSCLC
- Central nervous system (CNS) metastases
- Malignancy other than NSCLC
- Palliative radiotherapy for bone lesions inside the thorax
- Prior radiotherapy of bone marrow
- Known to be positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- Life expectancy < 6 months
- Woman of child-bearing potential who is pregnant or is breast feeding or who is not consenting to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment
- Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment
- Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products
- Other inclusion/exclusion criteria may apply
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966003
| United States, North Dakota | |
| Research Site | |
| Bismarck, North Dakota, United States, 58501 | |
| Australia, Western Australia | |
| Research Site | |
| Fremantle, Western Australia, Australia, 6160 | |
| Bulgaria | |
| Research Site | |
| Veliko Tarnovo, Veliko Turnovo, Bulgaria, 5000 | |
| Research Site | |
| Ruse, Bulgaria, 7003 | |
| Study Director: | MD | Amgen |
Additional Information:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01966003 History of Changes |
| Other Study ID Numbers: |
20120265 2013-000738-36 ( EudraCT Number ) |
| First Posted: | October 21, 2013 Key Record Dates |
| Results First Posted: | October 19, 2017 |
| Last Update Posted: | October 19, 2017 |
| Last Verified: | September 2017 |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Paclitaxel Albumin-Bound Paclitaxel Bevacizumab |
Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |